Systems and methods for manipulating medical devices

ABSTRACT

A method for treating a patient having thrombus includes providing a manipulation device including a housing configured to be supported by the hand of a user and having a distal and proximal end, a drive system disposed within the housing, and configured to rotate a rotation member, an engagement member coupled to the rotation member and configured to be removably coupled to an elongate medical device, an activation member carried by the housing such that it can be operated by at least a portion of the hand of the user when the housing is supported by the hand of the user, the drive system configured to apply motive force to the engagement member, securing an elongate member to the engagement member, introducing at least the distal end of the elongate member into a blood vessel adjacent a thrombus, operating the activation member to cause at least some rotation of the rotation member, which in turn causes at least some rotation of the distal end of the elongate member at or near the thrombus, and aspirating at least some of the thrombus with an aspiration catheter.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/256,488, filed on Sep. 2, 2016, which claims the benefit of priorityto U.S. Provisional Application No. 62/214,192, filed on Sep. 3, 2015,and U.S. Provisional Application No. 62/286,429, filed on Jan. 24, 2016,all of which are herein incorporated by reference in their entirety forall purposes. Priority is claimed pursuant to 35 U.S.C. § 120 and 35U.S.C. § 119.

BACKGROUND OF THE INVENTION

Guidewires and other elongate medical devices are configured to beplaced within conduits and cavities of the body. These devices may bemanipulated manually to move or track the devices through tortuous,obstructed, or stenosed passageways. Such maneuvers are oftentimeschallenging and require skill and experience. At times, it is impossibleto successfully move or track the devices to desired target locationswithin the body.

SUMMARY OF THE INVENTION

In a first embodiment of the present disclosure, a method for treating apatient having thrombus includes providing a manipulation deviceincluding a housing configured to be supported by the hand of a user,the housing having a distal end and a proximal end, a drive systemdisposed within the housing, and configured to rotate a rotation member,an engagement member coupled to the rotation member, and configured tobe removably coupled to an elongate medical device to transferrotational movement of the rotation member to rotational movement of anelongate medical device, an activation member carried by the housingsuch that it can be operated by at least a portion of the hand of theuser when the housing is supported by the hand of the user, and whereinthe drive system if configured to apply motive force to the engagementmember, securing an elongate member to the engagement member, theelongate member having a distal end configured for introduction into apatient's vasculature, introducing at least the distal end of theelongate member into a blood vessel adjacent a thrombus, operating theactivation member to cause at least some rotation of the rotationmember, which in turn causes at least some rotation of the distal end ofthe elongate member at or near the thrombus, and aspirating at leastsome of the thrombus with an aspiration catheter.

In another embodiment of the present disclosure, system for treating apatient having thrombus includes an aspiration catheter having a distalend, a proximal end, and an aspiration lumen extending between thedistal end and the proximal end and configured to be coupled to a vacuumsource, an elongate member having a distal end and a proximal end, andconfigured for placement through the aspiration lumen of the aspirationcatheter, a manipulation device including a housing configured to besupported by the hand of a user, the housing having a distal end and aproximal end, a drive system disposed within the housing, and configuredto rotate a rotation member, an engagement member coupled to therotation member, and configured to be removably coupled to the elongatemember to transfer rotational movement of the rotation member torotational movement of the elongate member, an activation member carriedby the housing such that it can be operated by at least a portion of thehand of the user when the housing is supported by the hand of the user,and wherein the drive system if configured to apply motive force to theengagement member to thereby move the elongate member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a view of a guidewire manipulation device being usedon a patient according to an embodiment of the present disclosure.

FIG. 2A illustrates a top view of the guidewire manipulation device ofFIG. 1.

FIG. 2B illustrates a side view of the guidewire manipulation device ofFIG. 1.

FIG. 3 frustrates a top open view of the guidewire manipulation deviceof FIG. 1.

FIG. 4 illustrates a bottom open view of the guidewire manipulationdevice of FIG. 1.

FIG. 5 illustrates a cross sectional view of the rollers of theguidewire manipulation device of FIG. 1.

FIG. 6 illustrates a side view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 7 illustrates a side view of the guidewire manipulation device ofFIG. 6 with a depressed trigger according to an embodiment of thepresent disclosure.

FIG. 8 illustrates a side view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 9 illustrates a side view of the guide-wire manipulation device ofFIG. 8.

FIG. 10 illustrates a perspective view of a guide-wire manipulationdevice according to an embodiment of the present disclosure.

FIG. 11 illustrates a side cross sectional view of the guidewiremanipulation device of FIG. 10.

FIG. 12 illustrates a side cross sectional view of the guidewiremanipulation device of FIG. 10.

FIG. 13 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10.

FIG. 14 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10.

FIG. 15 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10.

FIG. 16 illustrates a side open view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 17 illustrates a side open view of the guidewire manipulationdevice of FIG. 16.

FIG. 18 illustrates a side view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 19 illustrates a side open view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 20 illustrates a side open view of the guidewire manipulationdevice of FIG. 19.

FIG. 21 illustrates a side open view of a guidewire manipulation deviceaccording to an embodiment of the present disclosure.

FIG. 22 illustrates a side open view of the guidewire manipulationdevice of FIG. 21.

FIG. 23 illustrates a view of one embodiment of a guidewire manipulationdevice being used on a patient according to an embodiment of the presentdisclosure.

FIG. 24 depicts a schematic block diagram of a guidewire manipulationdevice according to an embodiment of the present disclosure.

FIG. 25 depicts a vertical cross-sectional view of a guidewiremanipulation device according to an embodiment of the presentdisclosure.

FIG. 26 depicts a portion of an actuator used in the guidewiremanipulation device of FIG. 25.

FIG. 27 depicts a perspective view of a hub of a chuck that impartsaxial motive force to a guidewire when using the guidewire manipulationdivisive FIG. 25.

FIG. 28 depicts a block diagram of a controller for a guidewiremanipulation device in accordance with an embodiment of the presentdisclosure.

FIG. 29 depicts a vertical cross-sectional view of alternativeembodiment of the guidewire manipulation device.

FIG. 30 depicts a partial perspective view of a portion of a guidewiredrive assembly for the guidewire manipulation device of FIG. 29.

FIG. 31 depicts a cross-sectional view of a portion of the housing forthe guidewire manipulation device of FIG. 29.

FIG. 32 depicts a vertical cross-sectional view of the guidewiremanipulation device of FIG. 29 having the actuator engaged to applyaxial motive force to the guidewire in accordance with one embodiment ofthe present disclosure.

FIG. 33 depicts a partial, vertical cross-sectional view of anotherembodiment of a guidewire manipulation device for imparting axial motiveforce to a guidewire.

FIG. 34 illustrates an aspiration catheter within a blood vessel beingused in conjunction with a guidewire which is moved by a guidewiremanipulation device, according to an embodiment of the presentdisclosure.

FIG. 35 illustrates an aspiration catheter within a blood vessel beingused in conjunction with a guidewire which is moved by a guidewiremanipulation device, according to another embodiment of the presentdisclosure.

FIG. 36 illustrates an aspiration catheter within a blood vessel used inconjunction with a guidewire which is moved by a guidewire manipulationdevice, according to another embodiment of the present disclosure.

FIG. 37 illustrates a plan view of a system for treating a patienthaving thrombus, according to an embodiment of the present disclosure.

FIG. 38 illustrates a plan view of a system for treating a patienthaving thrombus, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Embodiments of the present disclosure comprise systems and methods formanipulating one or more medical devices. The medical devices mayinclude elongated medical devices including, but not limited to:guidewires (guide wires), maceration devices, for example macerationdevices having an expending element (such as a basket), cutting devices,atherectomy devices, and a variety of different catheter shafts,including solid catheter shafts and hollow catheter shafts. Conventionalguidewire manual manipulation methods often involve applying torque tothe guidewire to aid its passage through tortuous, occluded, or stenosedconduits or vessels. The user may sometimes spin the guidewire withinthe fingers (e.g., gloved fingers) to create a torque which assists inmanipulating the guidewire through the challenging anatomy. Thistechnique is sometimes referred to as “helicoptering,” alluding to thespinning blades of a helicopter. This technique can be difficult toachieve because the typically small diameter of guidewires makes themdifficult to grip. Additionally, it may be difficult to apply necessaryfriction to the surface of the guidewire to cause them to rotate,because guidewires are often covered with a lubricious coating. Forsimilar reasons, it may be difficult to place a longitudinal force onthe guidewires with manual manipulation, including a back-and-forthlongitudinal force intended for placing an oscillatory motion on theguidewire.

FIG. 1 illustrates an embodiment of a guidewire manipulation device 100which is advanced over a guidewire 102. As seen in this figure, theguidewire 102 is introduced into a blood vessel of the patient (e.g., afemoral artery). The manipulation device 100 is slid over the guidewire102 and selectively locked on to the guidewire 102. As the guidewire 102is advance into the patient, the user operates the manipulation device100 to rotate or vibrate the guidewire 102 as appropriate.

For example, as a distal end of the guidewire 102 reaches an angled orcurved region of the vessel, the user activates the manipulation device100 to rotate the guidewire 102 (i.e., in a counter clockwise directionindicated by arrow 103), thereby causing the distal end of the guidewire102 to more easily advance through the angled or curved region. Inanother example, the distal end of the guidewire 102 reaches anobstruction (e.g., an embolism) but is unable to easily pass. The userthen activates the guidewire manipulation device 100 to vibrate (e.g.,by routing between a clockwise and counter clockwise direction quickly),thereby causing the distal end of the guidewire 102 to pass through theobstruction. In another example, the device 100 may include a multiple,preprogrammed rotation patterns appropriate for different vesselconfigurations (e.g., a 180 degree clockwise rotation followed by 180degree counter-clockwise rotation, a 90 degree clockwise rotationfollowed by 90 degree counter clockwise rotation or a 30 degreeclockwise rotation followed by 180 degree counter clockwise rotation).

FIGS. 2A and 2B illustrate external views of the guidewire manipulationdevice 100. The guidewire manipulation device 100 may also include amicroprocessor and memory connected to the motor and a button 108 forstoring and executing the preprogrammed rotation patterns. As seen inthese figures, the guidewire 102 passes through a passage along thelength of the guidewire manipulation device 100. Preferably, theguidewire manipulation device 100 includes a locking assembly in theform of a guidewire lock switch 106 which allows the user to selectivelylock the guidewire manipulation device 100 to the guidewire 102. In thisrespect, the guidewire manipulation device 100 can move relative to theguidewire 102 in an unlocked state, and can move the guidewire 102(rotationally and/or longitudinally) in a locked state.

The guidewire manipulation device 100 also preferably includes a powerindicator light 104 (e.g., an LED) which indicates if the device 100 ispowered on and a rotation button 108 which causes the guidewire 102 torotate. By pressing the button 108, the user activates the device 100.Optionally, the device 100 may include a button, switch or similarmechanism to toggle the device 100 between rotating in a clockwisedirection or a counter-clockwise direction. Alternately, the button 108may include multiple actuation techniques for determining clockwise orcounter-clockwise rotation (e.g., sliding forward or backward, multiplebutton presses, etc.).

Preferably, an outer container or casing 110 is composed of alight-weight material such as plastic and has an ergonomic shape that atleast partially fits in the user's hand. In this respect, the user cancomfortably operate the guidewire manipulation device 100 during aprocedure.

Referring to FIGS. 3 and 4, an interior view of the guidewiremanipulation device 100 within the outer easing 110 is illustratedaccording to an embodiment of the present disclosure. The guidewire 102is engaged by the device 100 with elongated rollers 120 (also seen inthe cross sectional view of FIG. 5). Preferably the device 100 includesat least three rollers, however, any number of rollers 120 are possible(e.g., 1-5 rollers). When; the button 108 is pressed, the rollers 120rotate, thereby rotating the guidewire 102. Preferably, the lock switch106 raises or lowers one or more of the rollers 120 in relation to theguidewire 102, so as to lock the guidewire 102 with the device 100 whenthe rollers 120 are pressed against the guidewire 102 and unlock theguidewire 102 from the device 100 when the roller(s) 120 are moved awayfrom the guidewire 102.

One or more of the rollers 120 are preferably driven by a motor 116which is powered by battery 114 (or alternately by A.C. power such as anoutlet). The motor 116 connects to the roller(s) 120 by a cam 119 madeup of a first linkage 118 connected to the motor 116 and a secondlinkage 112 connected to the roller(s) 120. In this respect, activationof the motor 116 drives the cam 119 and ultimately rotation of one ormore of the rollers 120.

FIGS. 6 and 7 illustrate another embodiment of a manual manipulationdevice 130 according to the present disclosure. The device 130 isgenerally similar to the previously described device 100, except thatthe rollers 120 and therefore rotation at the guidewire 102 is driven bya handle 126. For example, depressing the handle 126 rotates theguidewire 102 in a clockwise direction (arrow 122) and releasing thehandle 126 rotates the guidewire 102 in a counter clockwise direction(arrow 123). Additionally, a switch 124 is included to change a type ofrotation caused by the handle 126. For example, the switch 124 maychange a gear ratio and therefore the amount of rotation cause bydepressing the handle. In another example, the switch 124 may changedirections of rotation caused by depressing the handle 126. By manualactivation of the handle 126 by the user, the internal drive componentsdrive the rotation of the guidewire 102 without the need of a motor 116.

FIGS. 8 and 9 illustrate another embodiment of a manual guidewiremanipulation device 132 which is generally similar to the previouslydescribed devices 100 and 130. However, the device 132 includes aselectively locking thumb roller 134 on a distal end of the device 132.The thumb roller 134 includes a locked mode, seen in FIG. 8, in whichthe roller 134 is engaged with the guidewire 102, thereby allowing theuser to roll the roller 134 and thus the guidewire 102. The thumb roller134 also includes an unlocked mode, seen in FIG. 9, in which the roller134 is pulled distally from the casing 136, exposing space 138 anddisengaging the roller 134 from the guidewire 102. Thus, in the unlockedmode, the device 132 can be moved along the length of the guidewire 102.

FIGS. 10-15 illustrate another embodiment of a guidewire manipulationdevice 140 according to an embodiment of the present disclosure. Thedevice 140 is generally similar to the previously described device 100.For example, the device 140 includes a hand-held (e.g., configured to beheld within a user's hand), ergonomic, outer case 142 and a manipulationbutton 144. As best seen in FIGS. 11 and 12, the device 140 alsoincludes a motor 152 powered by a battery 154 and a guidewire passage158 configured for passing the guidewire 102.

Preferably, the device 140 includes a locking assembly in the form of alocking hub 146 (similar to the device 132) which allows the user toselectively lock the guidewire 102 with the device 140. The locking hub146 allows free movement of the guidewire 102 when positioned near thecase 142 (FIG. 11) and locks the guidewire 102 when the hub is pulledaway from the case 142 (FIG. 12). The hub 146 includes an interiorcavity with a top surface angled downward towards the case 142. Withinthe interior cavity is a locking wedge 150 which is located within awindow 149 of a tube 148 that exposes the guidewire 102. In the unlockedposition of FIG. 11, the hub 146 restrains the wedge 150 but does notpress down on the wedge 150, thereby allowing the guidewire 102 to slideunderneath the wedge 150. In the locked position of FIG. 12, the angledinterior surface of the hub 146 forces the wedge downward against theguidewire 102, preventing the guidewire from movement relative to thedevice 140. A perspective view of the wedge 150 can also be seen in FIG.15.

As seen in FIGS. 11-15, the motor 152 includes a worm 155 that engages afirst gear section 156B of shaft 156. A worm 156A of shaft 158 engagesgearing 148A on the outer surface of tube 148. In this respect, when themotor 152 is activated, it ultimately rotates the roller assembly, ortube 148. Thus, the hub 146 must be in a slid-out, locked position tocause the guidewire 102 to rotate.

As with all motorized embodiments described in this specification, thedevice 140 may also include a microprocessor and memory for storing andexecuting different rotation sequences (i.e., rotation directions androtation speeds).

FIGS. 16 and 17 illustrate a guidewire manipulation device 170 accordingto yet another embodiment according to the present disclosure. Thedevice 170 is generally similar to previously described embodiments,including an outer case 184 having an actuation button 176 that iscoupled to a battery 186 and a motor 178. The gear 180 of the motor 178is engaged with a gear 182 that is also engaged with a geared section181 on wedge tube 174.

A hub 172 includes an interior, angled passage that increases indiameter in a distal direction. The wedge tube 174 is partiallypositioned within the hub 172. In the unlocked position of FIG. 16, theangled passage of the hub 172 complements a distally expanding shape ofthe wedge tube 174, thereby preventing the wedge tube 172 from clampingor providing force on the guidewire 102 and thus allowing the guidewire102 to slide and rotate relative to the device 170. In the lookedposition of FIG. 17, the hub 172 is moved distally from the case 184,causing the smaller diameter of the interior passage of the hub 172 towedge or clamp on to the expanded distal end of the wedge tube 174.Thus, the wedge lobe 174 (preferably composed of a compressible,semi-compressible or deformable material) closes around the guidewire102, maintaining the position of the guidewire 102 relative to thedevice 170 and further allowing rotation of the guidewire 102.

FIGS. 18-20 illustrates another embodiment of a device 190 according tothe present disclosure. The device 190 is generally similar to thepreviously described devices. However, the device 190 includes a lockingassembly in the form of a guidewire lock activated by depressing atrigger 196. In this respect, the user can rotate hub 192, eitherclockwise or counter clockwise to respectively rotate the guidewire 102.

The device 190 is generally similar to the previously describedembodiments, including a motor 210 powered by a battery 208, a gear 214coupled to an output gear 212 of the motor 210 and to a geared portion200B of a wedge tube 200 and a case 194 to contain the components. Themotor 210 is controlled by a rocker switch 192 that is connected to afirst circuit board 202 which sends the position of the rocker switch192 to the second circuit board 206. The second circuit board 206includes a microprocessor and memory for executing a plurality ofrotation programs. These rotation programs direct the motor 210 to makepredetermined rotation movements such as in a single direction,exponentially increasing rotational speed, quick rotation to causevibration or a predetermined series of rotational movements. Thus, morecomplicated movements can be performed by the user.

The device 190 locks on to the guidewire 102 when the user releasestrigger 196 (see FIG. 19) and unlocks the guidewire 102 when the userdepresses trigger 196. The trigger 196 moves an outer tubing 198 whichis biased in a distal direction by a spring 204. The interior passage ofthe outer tubing 198 increases in diameter in a distal direction formingan inverted cone shape. An inner wedge tube 200 is positioned within thepassage of the outer tubing 198 and includes a wedge 200A that increasesin size in a distal direction of the device 190. The guidewire 102 islocated within a passage of the wedge tube 200.

When the trigger 196 is released, as in FIG. 19, the outer tubing 198 ismoved distally by the spring 204, causing the smaller diameter region ofthe inner passage of the outer tubing 198 to press against the wedge200A of wedge tube 200. The wedge 200 then compresses around theguidewire 102, locking the guidewire 102 in place relative to the device190. When the trigger 196 is depressed, as in FIG. 20, a portion of thetrigger 196 pushes the outer tubing 198 in a proximal direction, againstthe bias of the spring 204. The angled portions of the inner passage ofthe outer tubing 198 move away from the wedge 200 a, allowing the innerpassage of the wedge tube 200 to release the guidewire 102. Thus, theuser can selectively lock on to and rotate the guidewire 102 (with theroller assembly, including wedge tube 200) by releasing the trigger 196and pressing the actuation button 192.

FIGS. 21 and 22 illustrate another embodiment of a guidewiremanipulation device 220 according to the present disclosure. The device220 is generally similar to the previously described embodiments.Including a battery 234 powering a motor 236 which drives a wedge tube224 (via a gear 240 connected to geared region 224B and output gear 238)and an actuation button 228.

The device 220 further includes a locking mechanism assembly that locksthe lateral position of the guidewire 102. As seen in FIG. 21, when theuser releases the trigger 232, the device remains in a locked position,allowing the user to rotate the guidewire 102. As seen in FIG. 22, whenthe user depresses the trigger 232, the device remains in an unlockedposition, allowing the user to slide the device 220 along the guidewire102 and preventing guidewire rotation.

In the locked position, the trigger 232 maintains an outer tube 222 in aproximal position, proximally biased by a spring 226. The outer tubeincludes an inner passage that generally decreases in diameter in adistal direction. The inner surface of the outer tube 222 pressesagainst a wedge portion 224A of a wedge tube 224, causing the wedge tube224 to press against and lock onto the guidewire 102.

In the unlocked position, the trigger 232 pushes the outer tube 222distally, against the bias of the spring 226. The surface of the innerpassage of the outer tube 222 moves away from the wedge 224A, releasingthe wedge tube 224 from the guidewire 102.

The systems and methods disclosed herein further comprise a guidewiremanipulation device for selectively imparting motive force (rotationaland/or axial/longitudinal (linear) motion) to a guidewire. In use, sucha guidewire manipulation device is selectively locked to a guidewire andis activated to impart motive force to maneuver the guidewire to adesired location during an endovascular procedure. The motive forceapplied to the guidewire is selectively rotational or axial tofacilitate moving the guidewire through a vessel and/or penetratingocclusions.

FIG. 23 illustrates a view of a guidewire manipulation device 2100 beingused on a patient 2110 according to one embodiment of the presentdisclosure. In one embodiment, the guidewire manipulation device 2100 isa handheld device capable of fitting in the palm of a user's hand andbeing operated using one hand. In one embodiment, the guidewiremanipulation device 2100 is advanced over a guidewire 2102, i.e., theguidewire 2102 passes through a longitudinally oriented passage in thedevice 2100. During an endovascular procedure, the guidewire 2102 isintroduced into a vessel 2106 (e.g., a femoral artery) of the patient2110. The guidewire manipulation device 2100 is selectively locked tothe guidewire 2102. As the guidewire is advanced into the patient, theuser operates the manipulation device 2100 to impart motive force(rotational and/or axial motion) to the guidewire 2102, as appropriate.

For example, as a distal end 2108 of the guidewire 2102 reaches anangled, curved, stenosed, or occluded region of the vessel 2106, theuser locks the manipulation device 2100 to the guidewire and impartsrotational motive force to the guidewire 2102 (e.g., in acounter-clockwise direction indicated by arrow 2104), thereby causingthe distal end 2108 of the guidewire 2102 to more easily advance throughthe angled, curved, stenosed, or occluded region of the vessel 2106.Once advanced past the region, the device 2100 is unlocked from theguidewire and the guidewire can be further advanced through the vessel.In another example, the distal end 2108 of the guidewire 2102 reaches anobstruction (e.g., an embolism, including, but not limited to athromboembolism) but is unable to pass the obstruction. The user thenlocks the guidewire manipulation device 2100 to the guidewire 2102 andimparts a vibratory motion (e.g., rapidly oscillating between clockwiseand counter-clockwise rotation). Such motion causes the distal end 2108of the guidewire 2102 to pass through the obstruction. In anotherexample, when the distal end 2108 of the guidewire 2102 reaches anobstruction, the user locks the guidewire manipulation device 2100 tothe guidewire 2102 and imparts an axial motion (e.g., a linear movementof the guidewire 2102) to create a jackhammer effect. In anotherembodiment, the user may lock the device 2100 to the guidewire 2102 andsimultaneously impart both rotational and axial motion to the guidewire2102. In another embodiment of the present disclosure, a sequence ofpredefined guidewire manipulations (i.e., a pattern) may be producedusing a computer program for controlling the motion as described indetail below. Various motive patterns to be selectively used in varioussurgical situations can be selected from memory and applied to theguidewire.

FIG. 24 depicts a schematic block diagram of one embodiment of aguidewire manipulation device 2100. The guidewire manipulation device2100 defines an axially longitudinal passage 2204 through which theguidewire 2102 is threaded during use. The guidewire manipulation device2100 comprises a housing 2200, an actuator 2206, and a chuck 2202. Thechuck 2202 comprises a guidewire locking mechanism 2208. During use, thechuck 2202 is locked to the guidewire 2102 using the looking mechanism2208. Once locked, the actuator selectively imparts motive force(rotational motion and/or axial motion) to the guidewire 2102.

FIG. 25 depicts a vertical cross-sectional view of one embodiment of aguidewire manipulation device 2100. In this embodiment, the actuator2206 of FIG. 24 is divided into a rotary actuator 2206A and an axialactuator 2206B such that the device may selectively apply to theguidewire: no motive force, rotary motive force or rotary and axialmotive force.

Device 2100 comprises a housing 2200 typically formed into halves thatare glued, bonded, screwed, or otherwise affixed to each other to forman enclosure. Within the housing 2200 are defined slots 350 wherein areretained bushings 302A and 302B. The bushings 302A and 302B support anaxle 300 on its outer surface 310. The axle 300 defines the passage 2204extending axially through the axle 300. When in use, the guidewire 2102is threaded through the passage 2204.

The rotary actuator 2206A comprises the axle 300, a motor 328, a driveassembly 326, a controller 330, and a control switch 332. The driveassembly 326 couples rotational motion of the motor 328 to the axle 300using a plurality of gears, further described with respect to FIG. 26below. In one embodiment of the present disclosure, the controller 330is simply one or more batteries that are coupled to the motor 328 viathe control switch 332. In such an embodiment, the control switch 332may simply apply a voltage from the one or more batteries to the motor328 to cause the motor 328 to rotate. In its simplest form, the controlswitch 332 is a simple single-pole, single-throw (SPST), momentarycontact switch. In other embodiments, the controller 330 comprises aprogrammable microcontroller as described with respect to FIG. 28 below.In other embodiments, the switch 332 may apply voltage to cause themotor 328 to selectively rotate clockwise or counter-clockwise. Thecontrol switch 332 is generally mounted to be exposed to the exterior ofthe housing 2200 and facilitate manipulation by one hand of a user(e.g., a thumb activated push-button or slide switch.

The axle 300 is coupled to a chuck 2202. In one embodiment, the chuck2202 comprises a coupler 304, a hub 324 and a wedge 314. The coupler 304and the axle 300 have splined mating surfaces 342 for coupling therotational motion of the axle 300 to the chuck 2202, while allowing thecoupler 304 to move in an axial direction. The hub 324 is threaded ontothe coupler 304 at surface 312. The wedge 314 is located in a window 352defined by the coupler 304. The hub 324 retains the wedge 314 within thewindow 352. In a disengaged (unlocked) position, the hub 324 does notimpart pressure to the wedge 314 thereby allowing the guidewire 2102 toslide freely beneath the wedge 314 and through the passage 2204. To lock(engage) the guidewire into the lock mechanism 2208, the hub 324 isrotated relative to the coupler 304 such that the angled surface 316 ofthe hub 324 interacts with the top surface 308 of the wedge 314. As thehub 324 is moved relative to the coupler 304 via the mating threadedsurfaces 312, the wedge 314 is forced against the guidewire 2102.Consequently, the guidewire 2102 is captured between the wedge 314 andthe coupler 304 and thereby locked into the chuck 2202. Once locked, anymotion of the chuck 2202 (e.g., rotational and/or longitudinal) isimparted as motive force to the guidewire 2102.

Other embodiments of the present disclosure utilize other forms ofchucks. In a broad sense, any mechanism that can be used to selectivelylock the guidewire to a source of motive force may be used. Other formsof chucks having multiple jaws or compressive slotted cylinders areapplicable.

The coupler 304 comprises a spring seat 354 supporting a first end of aspring 306. The second end of spring 306 rests against a flange 322 thatextends from the inner surface of the housing 2200. The spring 306 isone embodiment of a resilient member that biases the coupler 304inwardly toward the axle 300. The coupler 304 further comprises a flange320 that extends radially from the outer surface of the coupler 304. Theflange 320 is positioned along the coupler 304 to limit the amount ofaxial movement that can be imparted to the chuck 2202. The flange 320abuts the housing flange 322. As such, the spring 306 biases the coupler304 to maintain contact between the flange 320 and the flange 322.

To impart axial (longitudinal) motion to the chuck 2202, the bottomsurface 356 of the hub 324 is dimpled. The surface 356 interacts with aprotrusion 336 extending from the exterior surface of the housing 2200proximate the surface 356 of the hub 324. Depending on the position ofthe hub 324 relative to the coupler 304, the spring 306 insures that theprotrusion 336 interacts with the dimpled surface 356. Upon locking thechuck 2202 to the guidewire 2102 and imparting rotation to the chuck2202, the guidewire 2102 moves in an axial direction as indicated byarrow 358. To disengage the axial motive force, the hub 324 is rotatedrelative to the coupler 304 along the threads 312 to decouple theprotrusion 336 from the surface 356. In this manner, the lockingmechanism 2208 retains the guidewire 2102 such that rotational motion ofthe axle 300 is imparted to the guidewire 2102 without imparting axialmotion. In this embodiment, the axial motion actuator 2206B comprisesthe hub 324, spring 306, coupler 304 and the housing 2200.

FIG. 26 depicts a cross sectional view of the drive assembly 326 of therotary actuator 2206A taken along line 26-26 of FIG. 25 in accordancewith one embodiment of the present disclosure. The drive assembly 326comprises a motor gear 400, an intermediary gear 402 and an axle gear404. The motor 328 of FIG. 25 is coupled to the motor gear 400 to impartrotational motion to the motor gear 400. In one embodiment, the axlegear 404 is formed as an integral part of this surface of the axle 300of FIG. 25. The intermediary gear 402 is designed to provide a gearratio between the motor gear 400 and axle gear 404. The diameters andthe number of teeth of each gear is considered to be a design choicethat will define the speed of rotational motion of the guidewire 2102 aswell as the oscillatory speed of the axial motion.

In other embodiments, the motor 328 of FIG. 25 may be coupled to theaxle via other forms of drive assemblies, e.g., direct drive, worm gear,and/or the like. The specific motor and drive assembly characteristicsare considered a design choice to develop specific guidewire rotationspeed and torque. In some embodiments, the drive assembly may beadjustable to facilitate creating specific speed and torque profiles oradjustments. One form of adjustments may be facilitated by the use of astepper motor that can be controlled with a pulse width modulated signalproduced by the controller, as discussed below.

An alternative embodiment for imparting rotary motive force inselectable directions uses a gear train comprising two larger diameterspur gears mounted on a common shaft that is driven constantly in onedirection by an electric motor. Each of the two spur gears has a sectionof its teeth, something over ½ its total number, removed. The removedsections of teeth are positioned such that only one or the other of twoadditional smaller spur gears, each located to be driven by one of thesecommon shaft gears, will be driven at a time. The two smaller spur gearsare then used one at a time to drive the gear on the axle, but thepositioning of one additional gear between just one of these drivinggears and the axle gear results in the rotational direction of the axlebeing reversed when that set is driving the axle gear.

Another embodiment, if only forward and reverse is required without anear constant rotational speed in either direction, has the spur gear onthe axle driven by a pivoted ¼ pie-shaped plate. The toothed curvedsection opposite the pivot near the tip would be configured to have thecorrect pitch radius to mesh with the axle spur gear. This pivoted gearsection plate would have, running upwards from its pivot, a slot in itsface in which a pin, mounted off-center and a disc, could slide up anddown freely. As an electric motor turns this disc in a constantdirection, it would cause the pivoted plate to wobble back and forth sothat its gear section drives the axle spur gear in one direction andthen in the reverse direction.

FIG. 27 depicts a perspective view of the hub 324 in accordance with oneembodiment of the present disclosure. The hub 324 comprises a surface356 having a plurality of dimples 504 and spaces 502 between the dimples504. The hub 324 further comprises a threaded interior surface 312. Thethreaded interior surface 312 is adapted to interact with a threadedexterior surface of the coupler 304 to adjust the position of the hubrelative to the coupler 304 and the wedge 314. The dimples 504 and thespaces 502 between the dimples 504 are adapted to interact with theprotrusion 336 to impart axial motion to the chuck 2202. The spacing ofthe dimples and the speed of the motor control the oscillation rate ofthe axial motion. Furthermore, the depth of the dimples 504 relative tothe spaces 502 on the surface 356 controls the travel distance of theaxial motion.

FIG. 28 depicts a block diagram of the controller 330 in accordance withone embodiment of the present disclosure. The controller 330 comprises amicrocontroller 600, support circuits 602, memory 604 and a power supply606. The microcontroller 600 may be one or more of many commerciallyavailable microcontrollers, microprocessors, application specificintegrated circuits (ASIC), and the like. The support circuits 602comprise well known circuits that facilitate the operation of themicrocontroller 600 including, but not limited to, clock circuits,cache, power supplies, input/output circuits, indicators, sensors,and/or the like. In one embodiment, the power supply 606 comprises oneor more batteries. In other embodiments, the power supply 606 maycomprise an AC to DC converter to allow the guidewire manipulationdevice to be plugged into a wall socket. In further embodiments, thepower supply 606 may comprise one or more batteries and a chargingcircuit for the batteries may be inductively coupled to a base charger.

The memory 604 may be any form of memory device used to store digitalinstructions for the microcontroller 600 as well as data. In oneembodiment, the memory 604 is random access memory or read only memorycomprising control code 608 (e.g., computer readable instructions) thatare used to control the actuator 2206 to impart motion to the guidewire2102. The programs utilized by the microcontroller 600 to control theactuator 2206 are generally controlled by the control switch 332 and/oranother input device.

In one embodiment of the present disclosure, the motor 328 is a steppermotor that is controlled using, for example, a pulse width modulatedsignal produced by the controller 330 to impart specific torque and/orspeed profiles to the motor 328. In some embodiments, predefinedprograms can be generated and selected through manipulation of theswitch 332 to enable a user to overcome specific types of obstructionswithin the path of the guidewire. For example, if a surgeon encounters aspecific type of embolism, a specific program defining the motion of theguidewire to overcome the obstruction can be selected and implemented.Various programs can be generated through empirical study of guidewireutilization in endovascular procedures. To select a particular motionpattern, the switch may be a slide switch having a plurality ofselectable positions, where each position corresponds to a differentmotion pattern.

FIG. 29 depicts a vertical cross-sectional view of a guidewiremanipulation device 650 according to an alternative embodiment of thepresent disclosure. In this embodiment, the use of axial motion isselected through manipulation of a mechanical switch 702. As with theprior embodiment, this embodiment selectively imparts to a guidewire: nomotive force, rotary motive force, or rotary and axial motive force. Thedevice 650 comprises a rotational actuator 2206A as described above withrespect to FIG. 25. In this embodiment, a coupler 700 comprises a springseat 750, a dimpled flange 710 and a switch stop 752. A slidable switch702 comprises an extension 704 that interacts with a switch seat 752.The switch seat 752 and the spring seat 750 define a space 706 thatcaptures the switch extension 704. Manipulation of the switch 702 causesthe coupler 700 to move axially along the surface that mates with theaxle 300. A spring 708 is positioned between the spring seat 750 and thehousing flange 322. The spring 708 biases the coupler 700 inwardlytoward the axle 300. The dimpled flange 710 radially extends from thecoupler 700. One surface of the dimpled flange 710 abuts the housingflange 322 to limit the distance the coupler 700 moves in an axialdirection. The dimpled flange 710 has a surface aligned with a dimpledsurface 712 of the housing 2200. When the guidewire 2102 is locked tothe chuck 2202 and the rotational actuator 2206A is activated, theguidewire 2102 rotates without any axial movement. As described furtherwith respect to FIG. 32 below, when the switch 702 is moved forward tocause the dimpled surface of flange 710 to engage the dimpled surface712, the guidewire 2102 axial motive force is imparted to the guidewire2102.

FIG. 30 depicts a partial perspective view of the coupler 700 inaccordance with one embodiment of the present disclosure. The coupler700 has an aperture 806 through which the guidewire 2102 is threaded.The dimpled flange 710 comprises a radially extending flange 802 havinga plurality of dimples 800 formed in the surface 801. In one embodiment,the dimples 800 are formed as a sequence of wedges. In otherembodiments, to cause axial motion of the chuck when the coupler 700 isrotated, the surface 801 of the flange 802 is varied such thatinteraction with a corresponding surface causes axial movement of thecoupler 700.

FIG. 31 depicts a cross-sectional view of the housing 2200 taken alongline 31-31 in FIG. 29. In one embodiment, the surface 712 comprisescorresponding protrusions shaped to interact with the dimples 800 in thesurface 801 of the coupler 700. In another embodiment, the surface 712may comprise complementary wedges 900 to the surface 801 of the coupler700. The shape of the wedges 900 defines, in part, the distancetravelled, the rate of acceleration of the guidewire 2102, and the speedof the oscillation of the guidewire 2102.

FIG. 32 depicts an embodiment of the guidewire manipulation device 650of FIG. 29 where the dimpled flange 710 has been engaged the protrusionsurface 712. In this manner, the switch 702 has moved the coupler 700forward to facilitate engagement of the surfaces 710 and 712. When thechuck 2202 locks to the guidewire 2102 and the rotary actuator isactivated, the guidewire 2102 rotates as shown in arrow 1002 and axiallyoscillates as represented by arrow 1000.

FIG. 33 depicts a vertical cross-sectional view of a portion of aguidewire manipulation device 1100. Device 1100 comprises an axialactuator 2206B that can be selectively utilized without impartingrotational motion of the guidewire. As such, with this embodiment, thedevice 1100 selectively imparts to the guide wire: no motive force,rotary motive force, axial motive force, or axial and rotary motiveforce.

In one embodiment, the device 1100 comprises a linear actuator 1116coupled to a shaft 1114 that interacts with a fulcrum 1112. The linearactuator 1116 imparts linear motion to one portion of the fulcrum 1112.The fulcrum is mounted upon a pivot point 1120 such that the fulcrum1112 rotates about the pivot point 1120 as a linear motive force isapplied to the fulcrum 1112. A second end of the fulcrum 1112 interactswith a coupler 1104. The coupler 1104, as with prior embodiments, has asplined surface that interacts with the axle 300 to impart rotationalmotion to the coupler 1104, as needed. The coupler 1104 comprises aspring seat 1108. A spring 1106 is positioned between the housing 1102and the spring seat 1108 to bias the coupler 1104 toward the axle 300.The fulcrum 1112 couples to the spring seat 1108 such that motion of thefulcrum 1112 axially moves the coupler 1104. In this manner, without anyrotational motion the linear actuator 1116 imparts axial motion to thecoupler 1104 and to guidewire 2102 locked in the chuck 2202.

In one embodiment, the linear actuator 1116 may be a solenoid,piezoelectric actuator, linear motor, rotary motor and ball screw orrack/pinion, and/or the like. In another embodiment, a hammer-drill typeassembly may be used to impart axial force to the guidewire.

The controller 330 in a manner similar to that described for controllingthe motor 328 of FIG. 25 may control the linear actuator 1116.

FIG. 34 shows an open distal end 3158 of an aspiration lumen 3160 of anaspiration catheter 3000 for aspirating thrombus within a blood vessel3600. A skive 3162 may be formed in a polymer jacket 3146 of theaspiration catheter 3000, to aid entry of a thrombus 3164 that isaspirated into the aspiration lumen 3160 (in the direction of arrow3180) by the combination of the vacuum created by a vacuum source (e.g.,VacLok® Syringe, vacuum bottle) and the injection of fluid into thedistal end of the aspiration lumen 3160, as described below. The skive3162 also minimizes the chances of the open distal end 3158 being suckedagainst a blood vessel wall 3166. A distal supply tube 3168 of theaspiration catheter 3000 has a closed distal end 3170. For example, itmay be occluded during manufacture using adhesive, epoxy, hot meltadhesive or an interference member, such as a metallic or polymericplug. However, in some embodiments, the aspiration catheter 3000 mayhave a blunt or non-angled tip, instead of the skive 3162.Alternatively, the distal supply tube 3168 may be closed off by meltinga portion of it. The distal supply tube 3168 has a lumen 3176 extendingits length and an orifice 3172 formed through its wall 3174 at alocation adjacent and proximal to the closed distal end 3170. Theorifice 3172 may have a diameter between about 0.0508 mm (0.002 inches)and about 0.1016 mm (0.004 inches), or about 0.0787 mm (0.0031 inches).The inner diameter of the distal supply tube 3168 may be between about0.3048 mm (0.012 inches) and about 0.4826 mm (0.019 inches), or betweenabout 0.3556 mm (0.014 inches and about 0.4318 mm (0.017 inches) orabout 0.3937 mm (0.0155 inches). The lumen 3176 of the distal supplytube 3168 is a continuation of an overall flow path emanating from afluid source (e.g., saline bag, saline bottle) including an extensiontubing (not shown). In some embodiments, the lumen 3176 of the distalsupply tube 3168 may taper, for example, from an inner diameter of about0.3937 mm (0.0155 inches) at a proximal portion to an inner diameter ofabout 0.2974 mm (0.011 inches) at a distal portion. In some embodiments,the equivalent of a taper may be achieved by bonding different diametertubing to each other, resulting in a stepped-down tubing inner diameter.In some embodiments, different diameter tapered tubing may be bonded toeach other, for a combination of tapering and step-down of diameter. Anoutput pressure wave (for example, of saline injected via a pump) causesa liquid injectate to flow through the flow path, including a distalsupply tube 3168 (arrow 3182), and causes a fluid jet 3178 to exit theorifice 3172 at a high velocity. The fluid jet 3178 serves to maceratethrombus 3164 that is sucked into the aspiration lumen 3160, and alsocan serve to dilute the thrombus. This maceration and dilution assuresthat there is continuous flow through the aspiration lumen 3160 so thatit will not clog. The fluid jet 3178 is configured to be containedwithin the aspiration lumen 3160, and to not exit into a blood vessel orother body lumen. A guidewire tube 3132 having a distal end 3136 and aproximal end 3137 and having a distal port 3139 and a proximal port 3141is secured to the aspiration catheter 3000 with attachment materials3186. Though the guidewire tube 3132 of FIG. 34 is shown having a lengththat is shorter than the length of the aspiration catheter 3000(sometimes referred to as a rapid exchange catheter), in otherembodiments, the guidewire tube 3132 may extend substantially the entirelength of the aspiration catheter 3000. In some embodiments, theaspiration catheter 3000 may have a length of between 100 cm and 180 cm,and the guidewire tube 3132 may have a length of 28 cm or less. In someembodiments, the guidewire tube 3132 may be a length of 25 cm or less.In some embodiments, the guidewire tube may have a length of 10 cm orless. In some embodiments the guidewire tube may have a length of 3 cmor less. In some embodiments, the guidewire tube may have a length ofbetween about 3 cm and about 28 cm. The guidewire tube 3132 may belocated adjacent (i.e., lateral) to the aspiration lumen 3160, or may belocated co-axially within the aspiration lumen 3160. An additionalguidewire 3102 may be used along with any aspiration catheter(including, for example, the aspiration catheter 3000) to facilitate themovement of aspirated or macerated thrombus through a catheter lumen,for example, through the aspiration lumen 3160 of the aspirationcatheter 3000. The guidewire 3102 is secured at its proximal end 3188(FIG. 37) to any of the embodiments of the guidewire manipulation device100, 132, 140, 170, 190, 220, 2100, 650, 1100. A distal end 3143 mayinclude a straight portion 3145 or a curved portion 3147, or acombination of a straight portion 3145 and a curved portion 3147. Theguidewire 3102 may include a curved portion 3149 which is not located atthe very distal end 3143. The curved portion 3147, 3149 may comprise asingle arc or multiple arcs, but may generally comprise any non-straightpattern. The one or more arcs may be contained within a plane, or theymay be three-dimensional. The curved portion 3147, 3149 may comprise ahelix, such as a single diameter helix or a tapering diameter helix. Thetapering diameter helix may taper such that the diameter increases as itextends distally, or such that the diameter decreases as it extendsdistally. In some cases, a fully straight guidewire 3102 may be used.

In FIG. 34, either the straight portion 3145 of the distal end 3143 orthe curved portion 3147 of the distal end 3143 (or both in combination)may be placed adjacent or within the thrombus 3164 by inserting theguidewire 3102 through the aspiration lumen 3160 of the aspirationcatheter 3000, and then operating the guidewire manipulation device 100,132, 140, 170, 190, 220, 2100, 650, 1100 to rotate, longitudinallycycle, or otherwise move the guidewire 3102. The movement caused at thedistal end 3143 of the guidewire 3102 serves to help to break up ormacerate the thrombus 3164, and also help to move the partially orcompletely macerated thrombus 3164 (or a portion thereof) towards theaspiration catheter 3000 and particularly towards the open distal end3158 of the aspiration lumen 3160 of the aspiration catheter 3000. Thecurved portion 3149 within the aspiration lumen 3160 of the aspirationcatheter 3000 also serves to facilitate the movement of the partially orcompletely macerated thrombus 3164 (or a portion thereof) through theaspiration lumen 3160 of the aspiration catheter 3000, towards aproximal end of the aspiration lumen 3160. The curved portion 3149 mayalso serve to help center the guidewire 3102 within the aspiration lumen3160 or to stabilize the guidewire 3102 as it is rotated orlongitudinally moved by the guidewire manipulation device 100, 132, 140,170, 190, 220, 2100, 650, 1100. In some cases, the guidewire 3102 may beslowly pulled proximally during the aspiration of the thrombus 3164, sothat the curved portion 3149 helps to translate portions of thrombus. Insome embodiments, the curved portion 3149 may be replaced by a straightportion. For example, a guidewire may comprise an outer coil extendingalong its longitudinal axis, which comprise external contours that willserve to macerate or translate a portion of thrombus. The guidewiremanipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100 may beoperated such that the guidewire 3102 is rotated in a direction suchthat the curved portion 3149 (or the straight portion of helical coil)rotates in a direction that preferentially moves the portion of thrombusproximally in the aspiration lumen, in a similar action to an impelleror Archimedes screw. If the aspiration lumen 3160 of the aspirationcatheter 3000 becomes clogged with thrombus or other embolus, theguidewire manipulation device 100, 132, 140, 170, 190, 220, 2100, 650,1100 may be attached to a guidewire 3102 that is already in place (i.e.,through a guidewire lumen) to guide the catheter, and then the guidewiremanipulation device may be activated to move (rotate, longitudinallytranslate, etc.) the guidewire 3102 to help dislodge the thrombus orother embolus so that it can be fully aspirated/evacuated and removedfrom the aspiration lumen 3160, thus eliminating the clog. The guidewire3102 or other elongate medical devices may be fabricated from a numberof different biocompatible materials, including, but not limited tostainless steels or shape-memory alloys such as nickel-titanium alloys(Nitinol).

In FIG. 34, both the aspiration catheter 3000 and the guidewire 3102 maybe inserted (separately or together) through a delivery catheter, suchas a coronary guiding catheter. FIG. 35 illustrates the aspirationcatheter 3000 and a guidewire 3102 inserted through a delivery catheter3151, such as a coronary guiding catheter, but in this case, theguidewire 3102 is radially adjacent the aspiration catheter, within anannulus between the interior of the delivery catheter 3151 and theexterior of the aspiration catheter 3000. Thus, the guidewire 3102 maybe moved or manipulated by the guidewire manipulation device 100, 132,140, 170, 190, 220, 2100, 650, 1100 such that the distal end 3143 aidsthe maceration or movement of the thrombus 3164 not only into theaspiration lumen 3160 of the aspiration catheter 3000, but also into thelumen 3153 of the delivery catheter 3151. The curved portion 3149 (or astraight portion) is configured to aid the movement of the thrombus 3164(or a portion thereof) through the lumen 3153 of the delivery catheter3151. In some cases, the guidewire 3102 may be slowly pulled proximallyduring the aspiration of the thrombus 3164, so that the curved portion3149 helps to translate portions of thrombus 3164. In other embodiments,two guidewires 3102 and two guidewire manipulation devices 100, 132,140, 170, 190, 220, 2100, 650, 1100 may be used, in a combination of themethods of FIG. 34 and FIG. 35. The aspiration catheters describedherein may include any standard aspiration catheter having one or moreaspiration lumens. Aspiration catheters used herein may include the ACE™or INDIGO® catheters produced by Penumbra, Inc. of Alameda, Calif., USA.

Aspiration catheters and aspiration systems may include those describedin U.S. Patent Application Publication No. 2015/0282821 to Look et al.,published Oct. 8, 2015, which is incorporated herein by reference in itsentirety for all purposes.

Aspiration catheters and aspiration systems may include those describedin U.S. Patent Application Publication No. 2015/0327875 to Look et al.,published Nov. 19, 2015, which is incorporated herein by reference inits entirety for all purposes.

FIG. 38 illustrates a system for treating thrombus 4246. The system fortreating thrombus 4246 includes a delivery catheter 3151 having a lumen3153 through which an aspiration catheter 3000 is placed. A guidewire3102 may be inserted either through the lumen 3153 of the deliverycatheter 3151, or (as shown in FIG. 38) through a lumen of theaspiration catheter 3000, for example, through the aspiration lumen 3160of the aspiration catheter 3000. The guidewire 3102 is configured to bemanipulated (rotationally and/or longitudinally) by a guidewiremanipulation device 4231 having a housing 4232 and a handle 4237. Theguidewire manipulation device 4231 may include any of the embodimentsdescribed herein, or may include embodiments of guidewire manipulationdevices such as those disclosed in co-pending U.S. patent applicationSer. No. 15/235,920, filed on Aug. 12, 2016 and entitled “System andMethod for Manipulating an Elongate Medical Device,” which isincorporated by reference herein in its entirety for all purposes. Thedelivery catheter 3151 has a proximal end 3192 and a distal end 3190,with the proximal end 3192 coupled to a y-connector 4244 by a luerconnection 4248. The luer connection 4248 may include in someembodiments a female luer attached to the proximal end 3192 of thedelivery catheter 3151 and a male luer at the distal end of they-connector 4244. A hemostasis valve 4250 at the proximal end of they-connector 4244 is configured to seal around a shaft 4252 of theaspiration catheter 3000, and may include a Touhy-Borst, a spring-loadedseal, a duckbill seal, or other seals. A connector 4254 is attached tothe proximal end 4256 of the aspiration catheter 3000. The connector4254 includes a central bore 4258 which is in fluid communication withthe aspiration lumen 3160, and which terminates in a connector 4261 (forexample, a female luer connector). In embodiments wherein the aspirationcatheter 3000 comprises a forced aspiration catheter, a port 4260 is influid communication with the lumen 3176 of the distal supply tube 3168(FIG. 34). Thus the port 4260 may be configured to be coupled to asource of pressurized fluid 4268 (e.g., normal saline). The connector4261 is configured to be coupled to a connector 4263 at the distal endof a y-connector 4265. The connector 4263 may comprise a male luer. They-connector 4265 includes a hemostasis valve 4267 (Touhy-Borst,spring-loaded seal, etc.) and a sideport 4269. The hemostasis valve 4267is configured to seal around the guidewire 3102. The sideport 4269 ofthe y-connector 4265 is configured to be coupled to a vacuum source4266. The sideport 4262 of y-connector 4244 may additionally beconfigured to be coupled to a vacuum source 4270, and/or may be used forinjections of fluids, such as contrast media.

The aspiration catheter 3000 includes an open distal end 3158, which mayinclude a skive 3162. The guidewire 3102 is shown in FIG. 38 having adistal end 3143 which includes a curved portion 3147 and a straightportion 3145, though other distal configurations are also contemplated,including curved only or straight only. The guidewire 3102 is shownextending through the aspiration lumen 3160 of the aspiration catheter3000 and proximally through the connector 4254 and through they-connector 4265. The guidewire 3102 may be secured at its proximal end3188 to a rotatable chuck 4207, which is rotatably carried by theguidewire manipulation device 4231. The chuck 4207 may be manipulated toselectively grip and ungrip (engage and unengage, lock and unlock, etc.)the guidewire 3102 via a collet, or any equivalent means. The guidewiremanipulation device 4231 is configured to be supported by the hand of auser, and includes the handle 4237 which has one or more controls 4243.The handle 4237 may extend in a generally perpendicular direction fromthe axis of the guidewire 3102 as it extends through the housing 4262,and may angle towards a distal end 4236 of the housing 4232 (as shown inFIG. 38) in a reverse gun handle grip. Alternatively, the handle 4237may have a standard gun handle grip (see FIG. 37), and thus may angletowards a proximal end 4234 of the housing 4232. The controls 4243 areshown in FIG. 38 carried on a distally-facing surface 4239 of the handle4237, and may be configured in this embodiment to be operated by one ormore finger of the hand of the user, which may include non-thumbfingers. The controls 4243 may include an activation button 4214 whichis configured to turn power on an off, for example, to power a motor(not shown) which is configured to rotate and/or longitudinally move theguidewire 3102. A control knob 4217 may be configured to increase ordecrease a rotation speed (e.g., of the motor) or to select a pluralityof different manipulation routines. The manipulation routines may bestored within memory that is carried within the guidewire manipulationdevice 4231, for example, on a circuit board. The circuit board mayinclude a controller, as described in relation to the other embodimentsherein. An exemplary manipulation routine may include rotating theguidewire 3102 in a first rotational direction eight rotations, and thenrotating the guidewire 3102 in a second, opposite, rotational directioneight rotations. Another manipulation routine may include rotatingcontinuously in a single direction. Another manipulation routine mayinclude rotating continuously in one direction while repeatedlytranslating the guidewire 3102 distally and proximally (longitudinalcycling). Alternatively, the controls 4243 may be carried on aproximally-facing surface 4238 of the handle 4237, and may be configuredto be operated primarily by the thumb of the hand of the user. The motormay be connected to the chuck 4207 directly, or by other drive elements,including gearing, which may be used to change speeds, torques, orrotational directions. The drive elements may include those described inrelation to any of the embodiments disclosed herein. In use, the vacuumsource 4266 may be coupled to the sideport 4269 of the y-connector 4265,and thrombus may thus be aspirated through the aspiration lumen 3160 ofthe aspiration catheter 3000. The vacuum source 4266 may comprise asyringe, a vacuum chamber, or a vacuum pump. Syringes with lockableplungers, for example syringes having volumes of between about 20 ml andabout 30 ml, may be used as the vacuum source. While performing anaspiration procedure, the user may simultaneously or sequentiallyoperate the guidewire manipulation device 4231 to rotate and/orlongitudinally move the guidewire 3102, in order to aid the macerationof the thrombus and/or the movement of the thrombus or pieces of thethrombus through the aspiration lumen 3160.

FIG. 37 illustrates a system for treating thrombus 5200. The system fortreating thrombus 5200 includes a sheath 5202 having a lumen 5204passing therethrough through which a microcatheter 5206 is placed. Aguidewire 3102 may be inserted a lumen 5208 of the microcatheter 5206.The guidewire 3102 is configured to be manipulated (rotationally and/orlongitudinally) by a guidewire manipulation device 5231 having a housing5232 and a handle 5237. The guidewire manipulation device 5231 mayinclude any of the embodiments described herein, or may includeembodiments of guidewire manipulation devices such as those disclosed inco-pending U.S. patent application Ser. No. 15/235,920, filed on Aug.12, 2016 and entitled “System and Method for Manipulating an ElongateMedical Device.” The housing 5232 has a proximal end 5234 and a distalend 5236 and the handle 5237 extends in a substantially radial directionfrom the guidewire axis of the housing 5232. Controls 5243 are carriedby a proximally-facing surface 5238, and include an activation button5214 and a control knob 5217, which may be configured similar to theactivation button 4214 and the control knob 4217 of the guidewiremanipulation device 4231 of the embodiment of FIG. 38. The user's handis configured to grip the standard gun handle grip of the handle 5237 bywrapping around the distally-facing surface 5239. The handle 5237 isdepicted in FIG. 37 angling toward the proximal end 5234 of the housing5232. The user may operate the controls 5243 using the user's thumb, ora combination of the user's thumb and one of the non-thumb fingers ofthe user's hand. A chuck 5207 is carried by the guidewire manipulationdevice 5231 adjacent the proximal end 5234 of the housing 5232 and isconfigured to rotate and/or longitudinally move the guidewire 3102 in asimilar manner to the chuck 4207 of FIG. 38. However, the guidewire 3102is configured to pass through the housing 5232 and a proximal end 3188of the guidewire 3102 is configured to be secured to the chuck 5207. Theguidewire manipulation device 4231 includes a locking element 5210carried adjacent the distal end 5236 of the housing 5232 which isconnectable to a connector 5211 which is coupled to a proximal end 5213of the microcatheter 5206. The locking element 5210 and the connector5211 comprise male and female luer locks, or may comprise other types oflocking connections which secure the connector 5211 with respect to theguidewire manipulation device 5231. When the locking element 5210 andthe connector 5211 are secured to each other, relative rotational and/orlongitudinal motion between the guidewire manipulation device 5231 andthe connector 5211 are inhibited. The sheath 5202 includes a proximalend 5233 and a distal end 5235, and may include a proximal internal seal5241, and a sideport 5245 having a luer 5247. In use, the user mayoperate the guidewire manipulation device 5231 (for example, by holdingthe handle 5237 and pressing the activation button 5214) while alsomoving pushing or pulling the microcatheter 5206 within the lumen 5204of the sheath 5202. Thrombus may be macerated by the distal end 3143 ofthe guidewire 3102. If desired, the thrombus may be aspirated throughthe lumen 5204 of the sheath 5202, by applying a vacuum (e.g., attachinga vacuum source, not shown) to the sideport 5245 of the sheath 5202. Thesheath 5202 may also be moved proximally or distally so that the distalend 5235 of the sheath approaches the thrombus or portions of thrombusor blood to be aspirated. If desired, the locking element 5210 of theguidewire manipulation device 5231 may be detached from the connector5211 of the microcatheter 5206, and a vacuum source (not shown) may beattached to the connector 5211 in order to aspirate thrombus or bloodthrough the lumen 5208 of the microcatheter 5206.

FIG. 36 illustrates an aspiration catheter 4000 within a blood vessel4600 having a blood vessel wall 4166. The aspiration catheter 4000 hasan aspiration lumen 4160 which is configured for aspirating thrombus4164 and also for placement of a guidewire 4102 which is configured totrack the aspiration catheter 4000 through the vasculature of a patient.A distal supply tube 4168 having a lumen 4176 is configured forinjecting pressurized fluid, such as saline. The pressurized fluid isinjected through the lumen 4176 and out an orifice 4172 into theaspiration lumen 4160. The orifice is located at the extreme distal endof the distal supply tube 4168. The output of the pressurized fluidthrough the orifice 4172 may comprise a jet 4178. Thrombus 4164 isaspirated into the aspiration lumen 4160. In some embodiments, the jet4178 macerates the thrombus 4164 as it passes by the jet 4178. Theguidewire 4102 may be attached to the guidewire manipulation device 100,132, 140, 170, 190, 220, 2100, 650, 1100, 4231 and moved by theguidewire manipulation device 100, 132, 140, 170, 190, 220, 2100, 650,1100, 4231 in one or more patterns including rotation motion 4180 and/orlongitudinal motion 4190. Either or both of these motions may beimparted on the guidewire 4102 to conjunctively aid the maceration ofthe thrombus 4164, and/or to aid in the transport of the thrombus 4164from distal to proximal through the aspiration lumen 4160. Therotational motion 4180 may include clockwise only, counter-clockwiseonly, or a combination of clockwise and counter-clockwise, for exampleback and forth rotational oscillation as described herein. Thelongitudinal motion 4190 may be movement imparted directly on theguidewire 4102 by the operation of the guidewire manipulation device100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231, or may be manuallyapplied by the user by moving the guidewire manipulation device 100,132, 140, 170, 190, 220, 2100, 650, 1100, 4231 back and forth (distallyand proximally). In some cases, the guidewire manipulation device 100,132, 140, 170, 190, 220, 2100, 650, 1100, 4231 may be gradually pulledwhile the guidewire 4102 is rotated by the guidewire manipulation device100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231. In some cases, thehandle of the guidewire manipulation device can be cyclically moveddistally and proximally while generally pulling the guidewiremanipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231proximally. For example, one cm distally, two cm proximally, one cmdistally, two cm proximally, etc. In some embodiments, the aspirationcatheter 4000 may consist only of a single lumen for aspiration andguidewire placement, without any forced injection (i.e., no distalsupply tube 4168). In some embodiments, the manipulation of theguidewire 4102 by the guidewire manipulation device 100, 132, 140, 170,190, 220, 2100, 650, 1100, 4231 performs a similar function to a“separator device” as is used with the ACE™ or INDIGO® aspirationcatheters produced by Penumbra, Inc. of Alameda, Calif., USA. The“separator device” is a guidewire type device with a ball orfootball-shaped portion at its tip that extends from an aspiration lumenand is pulled against the distal port of the aspiration lumen to helpdisrupt or macerate the thrombus/clot.

A variety of different elongate medical devices may be rotated,longitudinally moved, or otherwise manipulated by the embodiments of theguidewire manipulation device 100, 132, 140, 170, 190, 220, 2100, 650,1100, 4231 described herein, including embodiments of the elongatedmedical instrument and the macerator which are disclosed in U.S. PatentApplication Publication No. 2014/0142594 to Fojtik, published May 22,2014, which is incorporated herein by reference in its entirety for allpurposes.

In one embodiment a manipulation device includes a housing configured tobe supported by the hand of a user, the housing having a distal end anda proximal end, a drive system disposed within the housing andconfigured to rotate a rotation member, an engagement member coupled tothe rotation member and configured to be remotely coupled to an elongatemedical device to transfer rotational movement of the rotation member torotational movement of an elongate medical device, an activation membercarried by the housing such that the activation member can be operatedby at least a portion of the hand of the user when the housing issupported by the hand of the user, and wherein the drive system isconfigured to apply a combination of motive force components to theengagement member. In some embodiments, the combination of motive forcecomponents includes an alternating clockwise motion andcounter-clockwise motion. In some embodiments, the combination of motiveforce components comprises a rotational motion and a cyclic longitudinalmotion. In some embodiments, the activation member comprises a handlecoupled to the housing and configured to be operable by the hand of theuser. In some embodiments, the handle is configured to couple to thedrive system mechanically. In some embodiments, the rotation memberincludes a tube having a window. In some embodiments, the manipulationdevice further includes a motor operatively coupled to the drive system,wherein the activation member is configured to initiate operation of themotor. In some embodiments, the manipulation device further includesgearing coupled to the motor. In some embodiments, the activation memberincludes a switch. In some embodiments, the elongate medical deviceconsists of at least one of a guidewire, a basket, an expandable device,a catheter shaft, a macerator, or a cutting device. In some embodiments,the combination of motive force components comprises a helical motion.In some embodiments, the combination of motive force componentscomprises a jackhammer motion.

In another embodiment, a method for treating a patient having thrombuscomprises providing a manipulation device comprising a housingconfigured to be supported by the hand of a user, the housing having adistal end and a proximal end, a drive system disposed within thehousing and configured to rotate a rotation member, an engagement membercoupled to the rotation member, and configured to be removably coupledto an elongate medical device, an activation member carried by thehousing such that it can be operated by at least a portion of the handof the user when the housing is supported by the hand of the user, andwherein the drive system is configured to apply motive force to theengagement member, securing an elongate member to the engagement member,the elongate member having a distal end configured for introduction intoa patient's vasculature, introducing at least the distal end of theelongate member into a blood vessel adjacent a thrombus, operating theactivation member to cause at least some rotation of the rotationmember, which in turn causes at least some rotation of the distal end ofthe elongate member at or near the thrombus, and aspirating at leastsome thrombus with an aspiration catheter. In some embodiments, themotive force comprises a combination of motive force componentsincluding an alternating clockwise motion and counter-clockwise motion.In some embodiments, the combination of motive force componentscomprises a rotational motion and a cyclic longitudinal motion. In someembodiments, the activation member comprises a handle coupled to thehousing and configured to be operable by the hand of the user. In someembodiments, the handle is configured to couple to the drive systemmechanically. In some embodiments, the rotation member comprises a tubeincluding a window. In some embodiments, the manipulation device furthercomprises a motor operatively coupled to the drive system, wherein theactivation member is configured to initiate operation of the motor. Insome embodiments, the manipulation device further comprises gearingcoupled to the motor. In some embodiments, the activation membercomprises a switch. In some embodiments, the elongate medical deviceconsists of at least one of a guidewire, a basket, an expandable device,a catheter shaft, a macerator, and a cutting device. In someembodiments, the combination of motive force components comprises ahelical motion. In some embodiments, the combination of motive forcecomponents comprises a jackhammer motion. In some embodiments, theelongate member comprises a guidewire. In some embodiments, the distalend of the elongate member is substantially straight. In someembodiments, the distal end of the elongate member is curved. In someembodiments, at least a portion of the aspiration catheter extendsalongside at least a portion of the elongate member within a deliverylumen of a delivery catheter. In some embodiments, the at least somerotation of the distal end of the elongate member facilitates movementof the thrombus through the delivery lumen of the delivery catheter. Insome embodiments, the delivery catheter is a coronary guiding catheter.In some embodiments, the elongate member extends within a lumen of theaspiration catheter. In some embodiments, the elongate member extendswithin an aspiration lumen of the aspiration catheter. In someembodiments, the elongate member is rotatable within the lumen of theaspiration catheter. In some embodiments, the at least some rotation ofthe distal end of the elongate member facilitates movement of thethrombus through the lumen of the aspiration catheter. In someembodiments, the aspiration catheter comprises a supply lumen and anaspiration lumen, the supply lumen having a wall and a closed distalend, the aspiration lumen configured to couple to a vacuum source andhaving an interior wall surface and an open distal end, the wall of thesupply lumen having an orifice in fluid communication with the interiorof the aspiration lumen, the orifice located proximally of the open endof the aspiration lumen and adjacent the closed distal end of the supplylumen. In some embodiments, the method further comprises providing atubing set having a first conduit configured to couple the supply lumenof the aspiration catheter to a fluid source, and a pump componentassociated with the first conduit and configured to detachably couple toa drive unit, such that the motion from the drive unit is transferred tothe pump component such that resultant motion of the pump componentcauses fluid from the fluid source to be injected through the supplylumen of the aspiration catheter, and through the orifice into theaspiration lumen. In some embodiments, the pump comprises a piston. Insome embodiments, the orifice is configured to create a spray patternwhen pressurized fluid is pumped through the supply lumen such that thespray pattern impinges on the interior wall surface of the aspirationlumen. In some embodiments, the aspiration catheter comprises a tubularaspiration member having a proximal end, a distal end, and a lumen, andconfigured to at least partially extend out of the lumen of a deliverycatheter having a lumen, and into the vasculature of a subject, anelongate support member coupled to the tubular aspiration member andextending between a proximal end of the aspiration catheter and theproximal end of the tubular aspiration member, and an annular sealcomprising at least one annular sealing member coupled to the tubularaspiration member.

In another embodiment, a method for breaking up a thrombus or emboluscomprises providing a manually-operated guidewire manipulation devicecomprising a housing having a proximal end, an elongate body, and adistal end, a rotation member disposed within the housing and configuredto rotate with respect to the housing, a locking assembly operablycoupled to a distal end of the rotation member, the locking assemblyhaving a locked mode wherein the rotation member is engaged with theguidewire, and an unlocked mode wherein the rotation member isdisengaged from the guidewire, a handle coupled to the housing andconfigured to be operable by one hand of a user, and a drive systemoperably coupled to the handle, the drive system configured to rotatethe rotation member upon actuation of the handle by the one hand of theuser in a first direction with respect to the housing, thereby causingthe guidewire to rotate in a first rotational direction when the lockingassembly is in the locked mode, wherein the handle is configured to bereleasable by the user such that the handle when released moves in asecond direction with respect to the housing, the second directionopposite from the first direction, wherein the handle is configured tocause rotation of the rotation member in a second rotational directionopposite the first rotational direction when the handle moves in thesecond direction, thereby causing the guidewire to rotate in the secondrotational direction, securing a guidewire to the rotation member viathe locking assembly, the guidewire having a distal end extendingthrough the lumen of a catheter and into a patient's vasculature,operating the manually-operated guidewire manipulation device to causeat least some rotation of the rotation member, which in turn causes atleast some rotation of the guidewire, and aspirating at least somethrombus or embolus through the lumen of the catheter. In someembodiments, the catheter is an aspiration catheter. In someembodiments, the lumen is an aspiration lumen. In some embodiments, theaspiration lumen is also a guidewire lumen. In some embodiments, thecatheter is a guiding catheter.

In some embodiments described herein, instead of a chuck being rotated,luer lock connector may instead be rotated. For example, a rotatablemale luer lock connector may be coupled to a medical device (such as anelongated medical device, which may include a catheter), in order torotated the medical device.

In some embodiments, the medical device to be rotated, axially displacedor moved in any other pattern may comprise one or more of: a drill bit,a burr, for example, burr systems for specialized Craniotomy use. Insome embodiments, the system may include a safety stop. In someembodiments, the medical device to be rotated, axially displaced ormoved in any other pattern may comprise one or more of: a tapered tipdevice that is advanced by spinning (for example a skived catheter),cutting tools for bone work, gigli saw wires, hollow trephines forbiopsy (flexible or rigid), dissecting elements that slide or findchannels (and may in some cases be able to expand), retriever expandingstent-like structures to penetrate thrombus and subsequently expand oncein place, balloon like or other expandable structures that deliver drugsby rubbing against a vessel wall either by axial motion, rotation or acombination. It can be appreciated that by connection to any of theembodiments described herein, medical devices of a variety of types maybe manipulated into motion such as rotating (one or more rotationaldirections), and pecking (forward and back). Additionally, oscillatingaction may be used in a coaxial system to move two elements in relationto each other, to release particles, drugs, or other materials. In someembodiments, the medical device to be rotated, axially displaced ormoved in any other pattern may comprise one or more of: an endoscopictrocar introducer, via wire, a Veress needle introducer, a femaleuterine cervix fallopian tube traversing device for i.e. sterilitydevice implantation, a ureter traversing for i.e. kidney stonemanipulation, a filing system for root canals, a FESS (functionalendoscopic sinus surgery) or burr-like surgical device, asinusoidal/nasal access, a plastic surgery device for tunneling underlayers of skin dermis, fat, a neurosurgical nose access device, a deepbrain access device, for example a University of Pennsylvania Deep BrainStimulation (DBS) device. In some embodiments, the medical device to berotated, axially displaced or moved in any other pattern may compriseone or more of: a hollow fenestrated wire drug delivery which deliversdrugs while spinning, drugs such as G2B3 Inhibitors which may bedelivered at or into thrombus. In some embodiments, the medical deviceto be rotated, axially displaced or moved in any other pattern maycomprise one or more of: an aneurysmal wire/catheter navigation andliquid embolic dispensing device.

While the foregoing is directed to embodiments of the presentdisclosure, other and further embodiments may be devised withoutdeparting from the basic scope thereof.

What is claimed is:
 1. A method for treating a patient having thrombuscomprising: providing a manipulation device comprising: a housingconfigured to be supported by the hand of a user, the housing having adistal end and a proximal end; a drive system disposed within thehousing, and configured to rotate a rotation member; an engagementmember coupled to the rotation member, and configured to be removablycoupled to an elongate medical device to transfer rotational movement ofthe rotation member to rotational movement of an elongate medicaldevice; an activation member carried by the housing such that it can beoperated by at least a portion of the hand of the user when the housingis supported by the hand of the user; and wherein the drive system ifconfigured to apply motive force to the engagement member; securing anelongate member to the engagement member, the elongate member having adistal end configured for introduction into a patient's vasculature;introducing at least the distal end of the elongate member into a bloodvessel adjacent a thrombus; operating the activation member to cause atleast some rotation of the rotation member, which in turn causes atleast some rotation of the distal end of the elongate member at or nearthe thrombus; and aspirating at least some of the thrombus with anaspiration catheter.